DIA 2018

Clinical technology is broken, so what is being done to fix it?

By Melissa Fassbender

- Last updated on GMT

(Image: Getty/DigtialStorm)
(Image: Getty/DigtialStorm)
The need to improve visibility, enable faster study execution, and improve study quality, is driving the industry to unify its "broken" clinical trial operating environments, according to a report.

Veeva Systems​ previewed the Unified Clinical Operations Survey​ during the DIA 2018 Global Annual Meeting​ last month in Boston, MA.

Year after year, the survey has garnered increased participation, which Jim Reilly, vice president, clinical strategy, Veeva Systems, said exemplifies an increasing focus on addressing “broken”​ clinical technology.

This year – for the first time – Reilly told us he was excited because “there’s more positive spin than the gloom and doom of all the issues and everything that’s wrong.”

“People recognize that clinical technology is broken,”​ he said – but they are starting to do something about it.

According to the survey, nearly all respondents (99%) reported a need to unify clinical trial operating environments, and 87% said they have or plan to have, an initiative in motion to fulfill this need and improve trial performance.

The main challenge of siloed applications and processes is integrating multiple applications, according to three-quarters of the respondents. This, followed by reporting across multiple applications (57%) and managing content and data across applications (56%).

Respondents reported using an average of four applications to manage their clinical studies and more than one third (38%) use at least five applications.

The top drivers for unification are to improve visibility (75%), enable faster study execution (61%), and improve study quality (60%).

Technology: The window into clinical trial operations

The ICH E6 Good Clinical Practice (GCP) Guideline was finalized in 1996 but has since been updated to encourage the application of more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting.

Specifically, ICH E6 (R2)​ requires the sponsor to “ensure oversight of any trial-related duties and functions carried out on its behalf.”

“The onus is on the sponsor,”​ explained Reilly. “You have to have a better sense and command of what’s happening in your trials at all times … And what’s your window into that? Technology.”

The majority of respondents (84%) reported “significant deficiencies” with their current clinical trial management system (CTMS) applications, with more than 85% citing the inability to fully support functions such as governance and oversight, resource management, as well as issue and task management.

“If your technology supporting trial execution is broke, the integrations don’t work, the data is siloed, it’s stitched together, then you don’t have the visibility you need to drive improvement,”​ added Reilly.

However, all respondents said they want to improve use of CTMS in their trial operations. The top drivers of this are greater visibility (70%), more proactive risk mitigation (65%), and improved study analytics and reporting (61%).

“This message of the value and need to unify your clinical technology is starting to resonate,”​ Reilly noted.

Additionally, he said the industry is recognizing the need for key performance metrics (KPIs) and reporting capabilities “to learn about how they operate so that they can improve.”

“Those folks are recognizing they need a unified technology to do just that,”​ he added.

According to the survey, those using standardized operational metrics and KPIs to measure trial performance, manage risk, and implement process improvements reported fewer challenges, specifically as it pertains to study performance metrics and reporting (44% versus 66%, respectively) and visibility into trial master file (TMF) status (32% versus 45%, respectively).

As it pertains to TMF, Reilly said there has been a marked increase in the number of people who say they are now running a built for purpose trial master file instead of a file share or generic share point site.

Study start up: Where it all begins

There also has been an increased interested in having a bespoke solution for study start up, said Reilly – adding that it is one of “the bigger areas” ​in which uptake is expected.

“I think next year we are really going to start to see that take off,”​ he added.

Per the survey responses, 83% reported that their organizations currently have a study start-up improvement initiative underway.

Approximately half reported site contract and budgeting among the most challenging study start-up processes, followed by investigational review board (IRB) and ethics committee planning and approval (45%), and site identification and selection (41%).

As to be expected, the main driver for improving the study start-up process is speed. Streamlining site contract and budgeting approval cycles, and improving site feasibility and selection outcomes follow closely, cited by nearly half of the respondents.

“One of the biggest areas where if you move the needle you can improve clinical research is in how quickly you get your trial started up. I think people recognize that,” ​said Reilly.

“Improving start up is the pointy end of the stick, that’s where it all begins. If you get that right, you’re setting the course for the rest of your trial off on the right foot and you’re already on an idealized timeline.”

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